MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	EU2100X15B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a trilogy evo was alarming indicating the fio2 sensor had railed.There was no harm or injury reported.The device was not in patient use.The device was returned to a third-party service center, and those errors were noted but are not actionable error codes.Additional review of the downloaded event log revealed an o2 proportional valve stuck alarm.The device's oxygen blending module subassembly was replaced to address the issue.Additionally, an o2 regulation and low o2 inlet pressure alarms were observed.The oxygen blending module subassembly was replaced due to these errors also, although they would not affect the device's ability to deliver therapy as designed.The device's inlet foam filter and particulate filter were replaced per preventive maintenance protocol.

• Brand Name: TRILOGY
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 22480783
• Report Number: 2518422-2025-107283
• Device Sequence Number: 8544513
• Product Code: CBK
• UDI-Device Identifier: 00606959055674
• UDI-Public: (01)00606959055674
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: EU2100X15B
• Device Catalogue Number: EU2100X15B
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown